Vaccine safety in SA: Inoculation shows ‘significant reduction in deaths’

Minister of Health Dr Joe Phaahla, along with a panel of experts, convened a media briefing on Wednesday pertaining to the fight against Covid-19 and the vaccine rollout in South Africa.

Phaahla said we’re not out of the woods yet and suggested South Africa should remain at adjusted level 3 lockdown.

He said cases in Gauteng were decreasing while cases in the Western Cape had now “taken over”. Over the last seven days, the Western Cape took the lead with active cases and the number of hospitalisations.

“Despite the downward trend in Covid-19 cases, South Africa is still in its third wave. It’s like a relay race: as cases in one province go down, cases in another province take over.”

Vaccine efficacy in South Africa

Rigorous testing

All vaccines go through “a rigorous, multi-stage testing process, including large trials that involve tens of thousands of people”. These trials are specifically designed to identify safety concerns.

“Once a clinical trial shows that a Covid-19 vaccine is safe and effective, a series of independent reviews of the efficacy and safety evidence is required, including regulatory review and approval in the country where the vaccine is manufactured,” the health department said.

Phaahla said healthcare workers who have been immunised with the Johnson & Johnson vaccine between February and May had “experienced a significant reduction in deaths compared to before they were vaccinated”.

To date, more than 40,000 healthcare workers had received their vaccines during the Sisonke trial, with an additional 500,000 school staffers and thousands of police officers.

Symptoms not causal

The head of the SA Vaccination and Immunisation Centre (Savic), Professor Hannelie Meyer, said people should seek treatment if they experienced symptoms of concern, but should not assume the symptom was a reaction to the vaccine.

She said while coughing, for example, could indicate an underlying Covid-19 infection, it could also be linked to tuberculosis (TB) or community-acquired pneumonia.

“It is important for the public to know that for the vaccines we are currently using in SA, there were more than 43,000 volunteers in the phase three trials and this means that by the time they were authorised we already knew the short-term side effects.”

What is an ‘adverse event following immunisation’?

An adverse event following immunisation (AEFI) is any untoward medical event which follows immunisation and which does not necessarily have a causal relationship with the usage of the vaccine.

In addition, an adverse event of special interest (AESI) is a pre-specified medically significant event which has the potential to be “causally associated with a vaccine product”.

These events – which could include Guillain-Barré syndrome (GBS) and coronary artery disease – are carefully monitored and investigated to determine if there is a link to Covid-19 vaccines.

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How to report adverse events

Adverse events following immunisation can be reported at any health facility and the Covid-19 hotline – 0800-029-999 – or via the Med Safety App.

When an AEFI or AESI is reported, the National Immunisation Safety Expert Committee (NISEC) reviews data about the case and determines the likelihood of a causal association between the event and the vaccine received.

The case investigation is carried out by trained healthcare workers and the multi-disciplinary team is made up of epidemiologists, clinical psychologists, surgeons, nurses and clinicians.

Sinovac and AstraZeneca

Earlier this week, Phaahla said he was confident about the use of the Sinovac vaccine in South Africa, following the South African Health Products Regulatory Authority’s (Sahpra’s) approval of the vaccine back in July.

In addition, Phaahla said the AstraZeneca vaccine – which had shown to be effective against the Delta variant – “should be brought back into use”. Phaahla said the goal now was to vaccinate more than one million people every three days.

As of Thursday, South Africa recorded 14,271 new Covid-19 cases, bringing the cumulative number of confirmed laboratory cases to 2,568, 511 which represents a 22.5% positivity rate. An additional 473 deaths were reported.

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